MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 36"(90CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z347H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: what measures were taken to retrieve the broken piece? x-ray, the surgeon was able to grasp the pieces and remove them, a magnet was attempted unsuccessfully.Was there any additional tissue damage as a result of searching for the needle piece? no.Were x-rays taken to locate the needle pieces? yes.At what location was the needle found? surgical site; needle broke during closing.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? needle was removed during the case.Does a piece of the needle remain in the patient¿s tissue? if yes, what tissue structure is it located? no.If retained, what is the surgeon's opinion of consequences to the patient? n/a.What in the physicians opinion are the factors contributing to the event? na.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Event or Problem Description
It was reported that the patient underwent a periop procedure on (b)(6) 2018, and suture was used.During the procedure, the needle was broken in two pieces.The surgeon was able to remove the pieces before the end of the case.There were no patient consequences reported.Additional information has been requested.

• Brand Name: PDS II SUTURE 36"(90CM) 1 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7250977
• Report Number: 2210968-2018-70748
• Device Sequence Number: 11020847
• Product Code: NEW
• UDI-Device Identifier: 10705031060685
• UDI-Public: 10705031060685
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: Z347H
• Device Lot Number: LKM186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1